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Anti-Infective Closed to Enrollment

Study to evaluate inhaled AP-PA02 in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (Armata Phase 1b/2 MAD) (Armata AP-PA02-101 MAD)

This study will look at the safety and tolerability of inhaled AP-PA02, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. Multiple doses of the drug will be tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa to find the best dose.

 This study will take place in two parts that are both randomized and placebo-controlled. This means that some participants will receive the study drug and some participants will receive a placebo. In Part 2 of this study, researchers will test the safety, tolerability, and effectiveness of multiple doses of inhaled AP-PA02 at three increasing levels. They will do this by monitoring for adverse events. They will also track the drug’s effect on the body measuring how much Pseudomonas aeruginosa is in sputum.This study may require physical exams, lung function tests, sputum induction, expectorated sputum collection, and/or other measurements.

Eligibility

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    38 days

  • Number of Study Visits:

    8

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Armata

  • Study Drugs:

    AP-PA02

Study Sites

  • Closed to Enrollment

    California

    Children's Hospital of Los Angeles, Los Angeles, CA 90027

  • Closed to Enrollment

    Florida

    Tampa General Hospital, Tampa, FL 33606

  • Closed to Enrollment

    Idaho

    Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702

  • Closed to Enrollment

    Illinois

    Northwestern University, Chicago, IL 60611

  • Closed to Enrollment

    Iowa

    University of Iowa, Iowa City, IA 52242

  • Closed to Enrollment

    Kansas

    University of Kansas Medical Center, Kansas City, KS 66160

  • Closed to Enrollment

    Maryland

    Johns Hopkins University, Baltimore, MD 21205

  • Closed to Enrollment

    Massachusetts

    Boston Children's Hospital, Boston, MA 02115

  • Closed to Enrollment

    Massachusetts

    Massachusetts General Hospital, Boston, MA 02114

  • Closed to Enrollment

    Michigan

    University of Michigan, Michigan Medicine, Ann Arbor, MI 48109

  • Closed to Enrollment

    Michigan

    Children's Hospital of Michigan, Detroit, MI 48201

  • Closed to Enrollment

    New Jersey

    Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ 08901

  • Closed to Enrollment

    New York

    New York Medical College at Westchester Medical Center, Valhalla, NY 10595

  • Closed to Enrollment

    Ohio

    University of Cincinnati Medical Center, Cincinnati, OH 45267

  • Closed to Enrollment

    Ohio

    Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195

  • Closed to Enrollment

    Ohio

    Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106

  • Closed to Enrollment

    Ohio

    Nationwide Children's Hospital, Columbus, OH 43205

  • Closed to Enrollment

    Pennsylvania

    University of Pennsylvania, Philadelphia, PA 19104

  • Closed to Enrollment

    Pennsylvania

    University of Pittsburgh Medical Center, Pittsburgh, PA 15224

  • Closed to Enrollment

    South Carolina

    Medical University of South Carolina, Charleston, SC 29425

  • Closed to Enrollment

    Tennessee

    Vanderbilt University Medical Center, Nashville, TN 37232

  • Closed to Enrollment

    Utah

    Intermountain Cystic Fibrosis Center, University of Utah, Salt Lake City, UT 84132

  • Closed to Enrollment

    Washington

    University of Washington Medical Center, Seattle, WA 98195

  • Closed to Enrollment

    Wisconsin

    University of Wisconsin, Madison, WI 53792

Eligibility

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

  • Pseudomonas Status:

    Positive Respiratory Cultures Required

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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